Arbutus Biopharma announced that the Company was notified via verbal communication from the U.S. Food and Drug Administration that the AB-101 Investigational New Drug application has been placed on clinical hold. AB-101 is a novel, oral PD-L1 inhibitor designed to reawaken and boost the immune system of patients with chronic hepatitis B virus. The FDA indicated they will provide an official Clinical Hold letter to Arbutus within 30 days. Based on this communication, the Company no longer intends to report initial data from the single-ascending dose portion of the Phase 1 clinical trial in the second half of 2023.
Published first on TheFly
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